Home / Recalls / Taro Pharmaceuticals U.S.A., Inc. / D-0277-2019

D-0277-2019 Class II Terminated

Recalled by Taro Pharmaceuticals U.S.A., Inc. — Hawthorne, NY

Recall Details

Product Type
Drugs
Report Date
November 21, 2018
Initiation Date
October 19, 2018
Termination Date
November 3, 2020
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
8328 bottles

Product Description

children's allergy (cetirizine hydrochloride) Oral Solution, 1 mg/mL, ANTIHISTAMINE, Dye-Free, Sugar-Free, 4 FL OZ (120 mL) bottle, Distributed by Publix Super Markets, Inc., 3300 Publix Corporate Parkway, Lakeland, FL 33811, NDC 56062-106-08, UPC 0 41415 43573 5.

Reason for Recall

Failed Impurities/Degradation Specifications: unknown impurity higher than the specified limit was detected during routine stability testing.

Distribution Pattern

Nationwide in the USA

Code Information

Lot # 313345, Exp 12/18

Other recalls by Taro Pharmaceuticals U.S.A., Inc.

  • D-0633-2024 Class III — Hydrocortisone 1% & Acetic Acid 2% Otic Solution, 10 mL bottle, Rx only, Mfg by: (August 7, 2024)
  • D-0727-2022 Class III — Clotrimazole and Betamethasone Dipropionate Cream USP, 1%/0.05%,15 g tubes, Rx o (February 25, 2022)
  • D-0375-2022 Class I — Clobetasol Propionate Ointment USP, 0.05%, 60g tubes, Rx only, Mfd. by: Taro Pha (December 15, 2021)
  • D-0246-2021 Class II — Nortriptyline HCl Capsules, USP equivalent to 10mg base Mfd. by: Taro Pharmaceut (January 8, 2021)
  • D-0156-2021 Class II — RiteAid Pharmacy RIngworm Cream, Clotrimazole Cream USP, 1%, Antifungal NET W 0. (November 17, 2020)
  • D-0151-2021 Class II — Equate Athlete's Foot, Clotrimazole USP 1%, Antifungal Cream, Packaged as a) NET (November 17, 2020)
  • D-0153-2021 Class II — Kaiser Permanente Clotrimazole Cream USP, 1% Antifungal Cream, NET WT 1 oz (28.4 (November 17, 2020)
  • D-0159-2021 Class II — Athlete's Foot Cream, Clotrimazole Cream USP, 1%, Antifungal Cream, NET WT 1 oz (November 17, 2020)
  • D-0157-2021 Class II — Best Choice, Clotrimazole Cream, USP 1%, Antifungal, NET WT 0.5 OZ (14.2g), Dist (November 17, 2020)
  • D-0154-2021 Class II — Kroger Athlete's Foot Cream, Clotrimazole Cream USP, 1%, Antifungal, NET WT 0.5 (November 17, 2020)